植入式心脏起搏器主要不良反应发生率的Meta分析

Incidence of Major Adverse Events Associated with Cardiac Pacemaker Implantation:a Meta-analysis

背景植入式心脏起搏器在临床应用已有50年,挽救了数以万计患者的生命。目前,我国植入式心脏起搏器数量正在以每年15%左右的速度增长,其不良反应也日益受到人们的关注。但目前尚缺乏大样本的调查数据对植入式心脏起搏器不良反应发生率进行全面报道。目的系统评价植入式心脏起搏器不良反应发生情况。方法计算机检索中国生物医学文献服务系统(SinoMed)、中国期刊全文数据库(CNKI)、中文科技期刊全文数据库(VIP)和万方数据知识服务平台、PubMed、EMBase、Cochrane Library数据库及临床试验注册平台ClinicalTrails.gov,均从数据库最早收录时间检索至2016-11-01。中英文分别结合(植入式心脏起搏器)+(不良事件or不良反应or安全性)相关主题词和自由词进行检索。检索植入式心脏起搏器不良反应的发生情况,不良反应包括囊袋感染、电池提前耗竭、电极脱位/移位、电极断裂、电极穿孔、电极阈值升高、膈肌刺激症状、皮肤破溃红肿、感知不良/过度、死亡等10种主要不良反应及其他,采用SPSS 16.0和Meta-analyst统计学软件进行率的Meta分析,根据随访时间、发表年份、起搏器类型进行亚组分析。结果 Meta分析结果显示,植入式心脏起搏器组死亡发生率最高,为6.6%〔95%CI(4.8%,8.9%)〕,其次为其他〔4.5%,95%CI(4.0%,5.2%)〕、皮肤破溃红肿〔3.6%,95%CI(1.8%,7.0%)〕和电极脱位/移位〔3.4%,95%CI(2.9%,4.0%)〕,再次为电极阈值升高〔2.9%,95%CI(1.9%,4.5%)〕、感知不良/过度〔2.6%,95%CI(1.8%,3.8%)〕、电池提前耗竭〔2.3%,95%CI(1.4%,4.0%)〕等。总的不良反应发生率为7.5%〔95%CI(6.7%,8.4%)〕。结论植入式心脏起搏器导致的不良反应发生率较高,尤其是死亡、皮肤破溃红肿、电极脱位/移位等,应对患者进行密切监测与随访。

Background Implantable cardiac pacemakers have been applied to clinical use for 50 years,saving tens of thousands of lives.At present,this number has increased by 15% each year.Because of this,the adverse events of pacemakers are concerned by people.However,full scaled surveys with large samples on the incidence of adverse events associated with cardiac pacemaker implantations are still insufficient.Objective To systematically assess the incidence of adverse events of cardiac pacemaker implantation.Methods We searched the databases of SinoMed,CNKI,VIP,Wanfang Data Knowledge Service Platform,PubMed,EMBase,Cochrane Library,ClinicalTrials.gov for studies concerning the adverse events 〔including 10 major adverse events (pocket infection,premature battery depletion,electrode dislocation/displacement,electrode fracture,electrode perforation,elevation of the pacing threshold,diaphragmatic stimulation,skin ulceration or redness and swelling,under/over-sensing and death) and other adverse events〕 related to cardiac pacemaker implantation from their inception to November 1,2016 using the subject headings and free-text terms of“ implantable cardiac pacemaker” plus“ adverse event” or “adverse reaction” or “safety”,and “植入式心脏起搏器” plus “不良事件” or “不良反应”or“安全性”.Meta-analysis was performed with SPSS 16.0 and statistical software for meta-analysis.Subgroup analyses were conducted according to the follow-up period,publication year,and type of pacemaker.Results The most commonly reported adverse event was death 〔6.6%,95%CI(4.8%,8.9%)〕,followed by other adverse events 〔4.5%,95%CI(4.0%,5.2%)〕,skin ulceration or redness and swelling 〔3.6%,95%CI(1.8%,7.0%)〕,electrode dislocation/displacement 〔3.4%,95%CI(2.9%, 4.0%)〕,elevation of the pacing threshold 〔2.9%,95%CI(1.9%,4.5%)〕,under/over-sensing〔2.6%,95%CI(1.8%, 3.8%)〕,premature battery depletion 〔2.3%,95%CI(1.4%,4.0%)〕 and so on.The overall incidence of major adverse events was 〔7.5%,95%CI(6.7%,8.4%)〕.Conclusion The available evidence indicates that the incidence of major adverse events of cardiac pacemaker implantation is high,in particular,the death,skin ulceration or redness and swelling, electrode dislocation/displacement etc.,so patients with cardiac pacemaker implantation should be monitored and followed up closely as long as possible.